QUETIAPINE FUMARATE
- Product NDC
- 16729-132
- 11-digit product format
- 167290132
- Labeler code
- 16729
- Product ID
- 16729-132_438fdf1f-3027-fb5a-e063-6294a90ac8d4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- QUETIAPINE FUMARATE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA206252
- Marketing category
- ANDA
- Marketing start
- 2017-11-30
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- QUETIAPINE FUMARATE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| QUETIAPINE FUMARATE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 853201 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16729-132-10 | QUETIAPINE FUMARATE | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 8 |
| 16729-132-12 | QUETIAPINE FUMARATE | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 8 |
| 16729-132-17 | QUETIAPINE FUMARATE | 1000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1000 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-132 | QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE INC.] | 7 | Current NDC, Legacy NDC, 3 package rows | 20240118_72111c36-c625-434f-9f16-7f25e0ff75f3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16729-132-10 | 16729013210 | 30 in 1 BOTTLE | | | | | Historical |
| 16729-132-12 | 16729013212 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-132-12) | 2017-11-30 | 0000-00-00 | No | No | Current |
| 16729-132-17 | 16729013217 | 1000 in 1 BOTTLE | | | | | Historical |